Kornimate/medical-research-clean huggingface dataset:
a study of rilematovir (jnj-53718678) in adult outpatients with respiratory syncytial virus (rsv) infection

Conditions: Respiratory Syncytial Virus

Summary: the purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (rsv) lower respiratory tract disease (lrtd) symptoms.

rilematovir is an investigational rsv specific fusion inhibitor currently in development for the treatment of rsv infection in both adult and pediatric populations. the study will include a screening period (day -1 to day 1), a treatment period (day 1 to day 7/8 \[depending on timing of first dose\]), and a follow-up period (day 8/9 to day 35). the total study duration of the study for each participant will be up to 35 days. the study will evaluate efficacy and safety of rsv in adult outpatients (18-85 years) who are at high risk of rsv related disease progression and have at least moderate rsv disease. the efficacy assessments include evaluation with electronic patient-reported outcome (epro) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Eligibility criteria:
inclusion criteria: * presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (rsv) infection * has at least 2 symptoms of lower respiratory tract disease (lrtd), one of which must be scored as at least 'moderate' if the symptoms did not pre-exist before rsv onset, or one of which is scored worse than usual if the symptoms pre-existed * tested positive for rsv infection using a molecular-based diagnostic assay (polymerase chain reaction \[pcr\] or other) on a bilateral nasal mid-turbinate swab sample * has at least one of the following high-risk conditions that predispose them to rsv-related disease progression: a. age greater than or equal to (\>=) 65 years, b. congestive heart failure (chf), c. chronic obstructive pulmonary disease (copd), d. asthma * randomized to study intervention treatment within 72 hours after onset of any of the rsv symptoms or worsening of pre-existing symptoms * not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than \[\<\] 24 hours are not considered as hospitalization) exclusion criteria: * known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation * presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia * participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis b or c infection * immunocompromised conditions * living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
project 4, study 2: extended exposure to low nicotine content cigarettes in pregnant women

Conditions: Tobacco Use Disorder

Summary: study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an associate's degree. this study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. after a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.

some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. they will be included after the trial is complete.

Eligibility criteria:
inclusion criteria: * female * ages 18-44 years * gestational age ≤ 25 weeks exclusion criteria: * male * under 18 years old * over 44 years old * gestational age \> 25 weeks

Keywords: biomarkers of exposure compensatory smoking nicotine dependence reduced nicotine cigarettes tobacco withdrawal women pregnancy health disparities vulnerable populations
phase i-iia, to evaluate the safety, feasibility, and efficacy of the use of biocleft in the treatment of cleft palate.

Conditions: Cleft Lip and Palate

Summary: phase i/ii, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.

the initial phase of the trial is non-randomized, and involves the sequential recruitment of 5 eligible subjects with a minimum safety period of 30 days between them. all of them will be implanted with the autologous human palatal mucosa substitute of nanostructured fibrin-agarose generated by tissue engineering (biocleft), after reconstruction of the palate. once the 5th treated patient has reached 1.5 months of follow-up after the intervention (visit 8), the safety and feasibility data analysis will be carried out by the independent data safety and monitoring committee (interim analysis), after which will allow continuation to the randomized phase of the trial, if the results allow it. in the second phase, the rest of the patients (10) will be recruited, who will be randomized 1:1, such that 5 of these patients will be implanted with the investigational medication while undergoing standard surgical reconstruction. (uranostaphyllorrhaphy), while the other 5 will only undergo standard surgical reconstruction and will constitute the control group. the total number of patients to be included in the study will be 15, who will be followed for 24 months according to a protocolized scheme that includes 2 pre-implant visits, 1 implant visit and 9 post-implant evaluation visits.

Eligibility criteria:
inclusion criteria: * pediatric patients, of both sexes. * diagnosis of total unilateral non-syndromic cleft lip and palate (flpns) that will undergo surgery for correction. * children who have previously donated a sample of oral mucosa during the cleft lip repair procedure (cheiloplasty). * informed consent signed by one or both parents (or legal guardian) adequately informed of the study and willing to follow the trial procedures and instructions. exclusion criteria: * active infectious diseases. * allergies or hypersensitivity to any of the components/excipients of the investigational product. * severe hematological disorders/blood dyscrasias. * severe hepatic or renal dysfunction/failure. * serious endocrine disorders/dysfunctions. * malignant neoplasms * active hiv, hbv or hcv infection. * metabolic bone diseases (paget's disease, hypercalcemia, etc.). * children with cleft lip and palate who present other congenital malformations that, in the opinion of the researcher, could affect the result of the study or the interpretation of the results of the study. * any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.
characterization of two novel mutations in the apob gene

Conditions: Familial Hypobetalipoproteinaemia - Heterozygous Form; Low-LDL-syndrome

Summary: the pilot study has the target to evaluate the outcomes of two novel mutations in the gene of apolipoprotein b (apob). apob is the main part of the low-density lipoprotein (ldl). ldl is the main transporter of cholesterol from the liver to the periphery. the two novel mutations lead to a heavily truncated apolipoprotein b. therefore the patients show severely decreased apob and ldl-cholesterol levels. the acquired disease is known as "familial hypobetalipoproteinemia". beside the protection from cardiovascular disease due to decreased ldl-cholesterol, patients tend to show elevated serum aminotransferases, fatty liver and occasional cases of cirrhosis and carcinoma. to elucidate the differences in lipoprotein assembly the investigators aim to characterize the changes due to the mutations in the patients. family members not carrying the mutations are the control group. the assessment includes lipoprotein fractionation, mri scans of the liver and a thorough assessment of medical history of all patients to look for potential side effects of the mutation. the only intervention needed for the study is to draw blood samples of every participant. the necessary positive vote from the ethics committee of the medical university of innsbruck is given.


Eligibility criteria:
inclusion criteria: * full legal age * written informed consent * diagnosed hypobetalipoproteinemia * exception of it are the controls * controls have to be family members * exclusion of a truncating mutation in the apob gene exclusion criteria: * no diagnosed hypobetalipoproteinemia * no truncating mutation in the apo b gene * exception of it ar the controls

Keywords: apolipoprotein b cholesterol lipoprotein metabolism steatosis cirrhosis hepatocellular carcinoma
online self-help intervention for insomnia: with or without feedback

Conditions: Insomnia

Summary: the object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. in this study all participants receive an online self-help cognitive behavioral therapy (cbt) intervention consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility criteria:
inclusion criteria: * insomnia * access to internet * dutch citizen exclusion criteria: * alcohol or substance abuse * being suicidal * sleep apnea * schizophrenic or having a psychosis disorder

Keywords: insomnia intervention self-help internet
safety, efficacy, and tolerability of sna-120 in subjects with pruritus associated with psoriasis vulgaris

Conditions: Pruritus; Psoriasis Vulgaris

Summary: to characterize the efficacy, safety and tolerability of sna-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (pv) and pv itself.


Eligibility criteria:
inclusion criteria: * informed consent/assent and health insurance portability and accountability act (hipaa) authorization * stable pv for at least 6 months prior to screening * chronic pruritus of the pv plaques to be present for at least 6 weeks prior to screening * mild to moderate pv at screening and baseline * has a target plaque at baseline on the trunk and/or limbs * subject's plaques are amenable to treatment with a topical ointment medication * willing and able to comply with the study instructions and attend all scheduled study visits. * willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation * females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study * men who are sexually active and can father children must agree to use highly effective forms of contraception during the study exclusion criteria: * underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin * positive hepatitis serology * thyroid abnormalities that may impact itching * subjects with spontaneously improving or rapidly deteriorating pv and/or pruritus * current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis * active psoriasis or itch affecting the palmar/plantar regions * subjects with a clinical diagnosis of bacterial infection of the skin * any major medical illness or symptoms of a clinically significant illness that may influence the study outcome * any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study * known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that contraindicates participation * currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days of randomization/baseline (note: subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study) * female who is pregnant or lactating, or is planning to become pregnant during the study * subjects participating in any previous sna-120 (and/or ct327) clinical studies
effect of anterioposterior weight shifting training with visual biofeedback in subacute stroke

Conditions: Stroke

Summary: asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. according to albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. however, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. we aimed to investigate the effect of anterioposterior weight shifting training with visual biofeedback in subacute post-stroke patients on gait asymmetry and pattern. 40 subacute post-stroke patients with step length asymmetry were enrolled in this study. the subjects were randomly assigned into two groups. the training group received an additional anterioposterior weight shifting training with visual biofeedback 5 times per week for 4weeks. the control group received the usual gait training. the spatiotemporal and kinematic data were obtained during walking through 3d motion analysis. functional ambulation category, self-selected walking speed, maximum safe walking speed, berg balance test (bbt), fugl-meyer assessment (fma), medical research council score (mrc), functional independent measure-mobility, timed up and go test (tug) were assessed at pre, during, post- training, and 4week follow-up. those were compared between two groups by repeated measures anova.


Eligibility criteria:
inclusion criteria: 1. less than 6 months after onset of the stroke 2. can stand and walk independently 10m 3. k-mmse score of at least 15 4. have asymmetrical gait pattern with step length asymmetric ratio greater than 1.1 5. over 20 years of age. exclusion criteria: 1. quadriplegia 2. past history of stroke 3. past history of musculoskeletal disease or history of neurological diseases
pa tolerability, safety and pharmacokinetics in healthy volunteers

Conditions: Infections, Respiratory

Summary: this is a first-in-human (fih) study to explore the safety, tolerability and pharmacokinetics of pa after oral ascending dose administration to healthy male volunteers.

the first-in-human dose (fhd) trial is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing safety, tolerability and pharmacokinetics (pk) of single and multiple oral doses of pa in healthy male subjects. the study consists of two stages: single dose administration and multiple dose administration. the single dose administration stage includes 5 cohorts, multiple dose administration stage includes at least 4 cohorts (groups). each cohort includes 8 subjects (6 active drugs and 2 placebos). cohorts intake ascending doses of study drug. the dose of 1st cohort is 1,0 mg/ml, the doses for the following cohorts will be estimated by the data monitoring committee based on pharmacokinetics and safety results of previous group. for each subject study includes screening period, one baseline period on day -1, a treatment period (1 day - at single dose stage; 14 days - at multiple dose stage), followed by safety, pk, assessments up to 72-96 hours post dose. follow-up visits will take place on day 7 ; 30; 60 (single dose stage) and 30; 60; 90 (multiple dose stage).

Eligibility criteria:
inclusion criteria: * age 18 to 55 years * body mass index 16 to 30 * subjects should be in good physical and mental health based on medical history, clinical examination and laboratory investigations * subjects should have signed informed consent prior to screening and the clinical study after they have read and understood the objective, conduct, risks related to the study, and their rights as study participants * subjects should have signed informed consent for being tested for hiv * subjects should have signed informed consent to be tested for alcoholemia, use of cannabinoids, cocaine, morphine, benzodiazepines, barbiturates and amphetamine exclusion criteria: * subjects should not have evidence of any physical and/or mental health issues at screening and/or results of any clinical, laboratory and/or technical procedures at screening outside of the normal range * subjects should not be taking any concomitant medication * subjects should not have a history of allergies, hypersensitivity or intolerance to iodine or iodide or to medicines containing iodine such as contrast media used for radiologic examinations * subjects should not have a history of addiction or abuse of drugs or alcohol * subjects should not be in a position of subordination or other dependence on persons involved in the study such as sponsor, investigators, or any other person or institution interested in its results * subjects should not be members of the armed forces or prison inmates * subjects should not have positive serology for hepatitis b, hepatitis c or hiv * subjects should not have any apparent functional and/or physical defects which may or interfere with the study or distort results

Keywords: safety iodine complex pharmacokinetics antibiotic potentiator
enhancing spatial navigation using non-invasive brain stimulation

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: remembering how to travel from one location to another is critical in everyday life, yet this vital ability declines with normal aging and can be further affected by conditions that disproportionately affect the elderly, such as vision loss or progressive dementia. human and animal research has shown that two distinct memory systems interact during navigation. the first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of key features or landmarks to develop and use a mental map of the environment. this approach involves brain regions that are critical for new learning and memory but that decline with age. the second, referred to as egocentric navigation, is inflexible and relies on "habit" memories that link specific features with specific directions. this approach relies on brain regions that are critical for "automatic" responses and that are relatively unaffected by age. the main problem is that allocentric navigation declines with age and is accompanied increased dependence on egocentric navigation. this change increases the risk of becoming disoriented or "lost" when traveling in unfamiliar areas or even when traveling new routes in familiar areas. therefore, the main goal of this project is to examine whether non-invasive brain stimulation, specifically transcranial direct current stimulation, can improve allocentric navigation in healthy older adults and patients with mild cognitive impairment. participants will complete two functional magnetic resonance imaging sessions while learning new environments. before one of these sessions, participants will receive active brain stimulation over the parietal cortex. before the other session, participants will receive sham brain stimulation over the parietal cortex. the effects of this stimulation will be evaluated using both an allocentric and an egocentric memory test. physiologic effects will be evaluated using both task-based and resting-state mri.


Eligibility criteria:
inclusion criteria: general inclusion criteria (all participants): * all medications stable for approximately 1-2 months; * no history of severe mental illness; * no current untreated alcohol or substance abuse/dependence; * english as native and preferred language; * mri-compatible if taking part in fmri studies * able to give informed consent. mci inclusion criteria: * diagnosis of amnestic mci based on criteria set forth by petersen (2004). additionally, other potential causes of cognitive deficit ruled out by the referring physician; healthy older adults * intact cognitive functioning as measured by neuropsychological testing exclusion criteria: * history of neurological disease or injury * history of severe mental illness * current untreated alcohol or substance abuse * other conditions may exclude; please discuss with contact

Keywords: aging alzheimer's disease/dementia cognitive disorders imaging magnetic resonance imaging (mri) neurology physical medicine & rehabilitation transcranial direct current stimulation
atrial fibrillation symptoms and pain sensitization

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common sustained arrhythmia and the number of patients with af is expected to increase substantially in the coming decades. one third of patients with af report no af-associated symptoms, but up to one fourth report severe symptoms such as chest pain. it is well recognized, but unclear why patients' experience of af-related symptoms, including chest pain, varies so much. patients with chronic pain show a high degree of central sensitization, i.e. facilitated pain responses to repeated painful stimulation and impaired conditioned pain modulation, compared with controls. it is possible that patients with symptomatic af may have developed pronounced pain sensitization even in the absence of chest pain as a symptom. no previous study has investigated pain sensitization in patients with af. the primary objective is to assess differences in pain sensitization in patients with symptomatic af compared with patients with asymptomatic af. secondary objectives are to study the association of age, sex, af duration, comorbidities and health-related quality of life to pain sensitization. a total of 30 patients with permanent af (15 symptomatic and 15 asymptomatic) will be recruited. patients will complete an af-specific symptom score and a generic health-related quality of life questionnaire, and physicians will assess af-related symptoms. quantitative sensory testing recordings will be collected by pressure algometry. assessment of temporal summation of pressure pain and conditioning pain modulation will be used to investigate the involvement of pain sensitization. this preliminary pilot study will be used to estimate sample size for a larger study in which both patients and control subjects will be recruited, to further investigate whether patients with symptomatic af have increased pain sensitization compared with patients with asymptomatic af and controls. the studies may have an impact on individualized management of patients with af in the future.


Eligibility criteria:
inclusion criteria: * male or female subjects 20 to 75 years old * permanent af * previously completed af-6 * written informed consent exclusion criteria: * paroxysmal or persistent af * previous pulmonary vein isolation * psychiatric or cognitive condition * pregnancy * previous/current drug or alcohol abuse * previous neurological or concomitant musculoskeletal condition * continuous analgesic medication

Keywords: atrial fibrillation symptoms quality of life pain conditioning pain modulation temporal summation